Data and Safety Monitoring Committees in Clinical Trials

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Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author's experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials. Leading you through the types of reports for adverse events and lab values, the author presents the statistical requirements of data monitoring committees and gives advice on how statisticians can best interact with physician members of these committees. He also shows how physicians think differently about safety data than statisticians, proving that both views are needed.

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Editorial Reviews

From the Publisher
"I found this book very useful as a clinical biostatistician with little experience with serving on a DMC. But also biostatisticians with more experience in DMCs can profit from this book since it helps in evaluating their own performance. Though the book primarily focuses on pharmaceutical industry trials, it is almost equally useful for those working on investigator-initiated trials."
—Theo Stijnen, ISCB News, December 2013

"This is an excellent book to stand alongside (primarily) Ellenberg et al. and (to a lesser extent) DeMets et al. … an excellent book not only for those who might sit on a DMC but also for the many people who have to set up DMCs, provide reports or data to them and, very importantly, receive their recommendations and have to act on them."
—Simon Day, Pharmaceutical Statistics, 2011, 10

"Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC. As a junior statistician, I found the end-of-chapter Q&A section to be invaluable, because it gives a behind-the-scenes peek at DMC meetings and interactions with sponsors. … the author provides virtually all relevant topics pertaining to a DMC with clarity and insight. … some readers with advanced statistical background will find this text nicely complements the book by Proschan, Lan, and Wittes (2009). … In summary, audiences ranging from novice clinical research practitioners to biostatisticians will find this comprehensive guide to data and safety monitoring committees a valuable addition."
The American Statistician, November 2010, Vol. 64, No. 4

"Jay Herson provides a concise overview of DMCs in a useful and accessible format. For someone new to the area, this text will provide a valuable introduction quickly and effectively. At the same time, the presentation style will allow those with more knowledge to move through the material expeditiously, and they will also benefit. … a valuable introduction to DMCs. … an excellent overview of a complex subject. The material is presented in a very accessible format and is particularly well suited to new DMC members, or those considering such an opportunity. The material is very useful, the presentation is effective, and a strong recommendation is appropriate."
Biometrics, March 2010

"When searching for books about DSMCs, you will find that Ellenburg et al. (2002) published a book with an almost identical title to Herson’s. … overall I would recommend Herson’s book as more readable and detailed. … This book would be particularly useful for anyone who becomes a DSMC member for the first time or for sponsors so that they can have a greater understanding of the DSMC’s role."
—Andrea M. Rehman, London School of Hygiene and Tropical Medicine, Journal of the Royal Statistical Society, Series A, 2010

"This book, lively and readable and reflecting real-world experiences and lessons from DMC safety monitoring, is a useful complement to other available texts on this subject."
—Paul P. Gallo, Novartis Pharmaceuticals, Journal of Biopharmaceutical Statistics, 2009, Issue 6

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Product Details

Meet the Author

Jay Herson is a professor at Johns Hopkins University in Baltimore, Jay Herson. During the past 30 years he has developed methods for design and analysis of clinical trials with planned interim analyses and sample size re-estimation. He organized and chaired the first data monitoring committee in the pharmaceutical industry and helped the FDA draft a guidance document on data monitoring committees.
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Table of Contents

What Is a Data Monitoring Committee (DMC)?
Some Definitions
DMC in Federal Government–Sponsored Clinical Trials versus Pharmaceutical Industry Clinical Trials
Some Recent History
DMC’s Place in the Drug Development Cycle6
Pharmaceutical Industry Demographics

Organization of a Safety Monitoring Program for a Confirmatory Trial
Members of the Safety Monitoring Team
How Is a DMC Created?
Conflicts of Interest
Liability and Indemnification
Sponsor DMC Relationship
Interdisciplinary Training .


DMC Charter
Types of Meetings
Orientation Meeting
Data ReviewMeetings
Ad Hoc Meetings

Clinical Issues

Goals of Safety Analysis .
Safety Data
Deaths .
Impact of Multinational Trials

Statistical Issues

Goals of Statistical Analysis
Useful Data Displays
Analysis Methods—Frequentist
Analysis Methods—Likelihood
Analysis Methods—Bayesian.

Bias and Pitfalls

What Is Bias?
Sources of Bias.
Knowledge of Treatment Assignment
Reporting Bias
Competing Risks

Data Monitoring Committee Decisions
Types of DMC Decisions 1
Decision-Making Environment .2
Risk versus Benefit Analyses2
When a Safety Issue Arises.3
Information beyond the Present Trial.8
Final Meeting2
Special Problems with Infant Pharma Companies2
DMCounselor .3

Emerging Issues9
Issues in Technology.0
Issues Due to Maturing of DMC Processes and Evolution of the Pharmaceutical Industry
Resignation from a DMC.0
DMCounselor .1

List of Abbreviations3

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